Change Healthcare Recalls Horizon Cardiology Hemo Software Due to Medication Discrepancies
Change Healthcare Israel Ltd. is recalling 125 units of Horizon Cardiology Hemo software because it fails to notify users of medication discrepancies, potentially affecting patient data and reports.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that can lead to incorrect medication data in patient records and reports. While no specific injuries or illnesses are reported in the source text, the risk of harm from medication discrepancies in a clinical setting justifies a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Change Healthcare Israel Ltd. is recalling 125 units of Horizon Cardiology Hemo software, specifically versions 11.x and 12.x. The recall is due to a software defect where users are not notified of procedure medication discrepancies between the Vitals and Meds, Procedure Notes, and Patient Common Data screens.
This discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician's Report. Additionally, it may impact customers who have implemented an outbound interface of procedure results.
The affected software was distributed nationwide to 43 states and internationally to Australia, Canada, Germany, Ireland, Israel, and the United Kingdom. Healthcare facilities using this software should contact Change Healthcare for further instructions on resolving the data discrepancy issue.
The recalled product
- Product
- Horizon Cardiology Hemo
- Manufacturer
- Change Healthcare Israel Ltd.
- Category
- Medical Device — Software
- Affected units
- 125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version 11.x and 12.x
Distribution
Part of a larger recall action
This product is one of 2 recalled by Change Healthcare Israel Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Change Healthcare Israel Ltd.
See all →- HighMcKesson Cardiology Hemo Software Recalled for Medication Data Discrepancies
FDA (Devices) · 2019-06-05
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